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United States · US · US:35573-447_81914a50-0e77-480d-aec5-2889b31a66d3
Leflunomide
Orange BookUNIISPLATC L04AK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBurel Pharmaceuticals, LLC
CountryUS (United States)
ATC codeL04AK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11355734473030 TABLET, FILM COATED in 1 BOTTLE (35573-447-30)
Annotations
UNII (FDA Substance ID)
G162GK9U4W
LEFLUNOMIDE
RxCUI 27169
Orange Book
A213497
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G162GK9U4W",
"rxcui": "27169",
"inchikey": "VHOGYURTWQBHIL-UHFFFAOYSA-N",
"display_name": "LEFLUNOMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e76d7767-744f-4e52-956d-e59f7a924826": {
"match": "brand_token",
"title": "LEFLUNOMIDE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "102",
"published_date": "2026-03-18"
}
},
"productid": "35573-447_81914a50-0e77-480d-aec5-2889b31a66d3",
"productndc": "35573-447",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213497",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "May 10, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "May 10, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEFLUNOMIDE",
"proprietary_name": "Leflunomide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213497",
"marketing_category": "ANDA",
"nonproprietary_name": "leflunomide",
"start_marketing_date": "20220103",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code L04AK01.
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